Thursday, April 01, 2010

Making Commercial Sen$e of Genzymes' apo-B Inhibitor Mipomersen

Mipomersen is an antisense inhibitor of apo-B protein synthesis, the first drug of its type. Genzyme (GENZ-$51.83) intends to first seek approval in the U.S. and Europe for mipomersen in those patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic disorder affecting one in a million people, in the first half of 2011.

Investigators believe mipomersen could be a valuable addition to the drugs used in the management of HoFH and could prove useful in the management of other high-risk, patients with severe hypercholesterolemia (resistant to existing lipid-lowering drugs)

Recent trial results, however, have raised questions about mipomersen’s safety and tolerability, as 76 percent and 12 percent of patients in the mipomersen-treated group had injection-site reactions and increased liver enzymes of three times or more the upper limit of normal (with MRI findings of increased intra-hepatic fat content too).

Two experts on antisense inhibitors of apo-B protein synthesis, R. Dermot Neely (Royal Victoria Infirmary, England) and John J Kastelein, (Chairman of the Department of Vascular Medicine at the Academic Medical Centre Amsterdam), share their insights on the commercial prospects of mipomersen.
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Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

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